GIV·IN PV GIVINOSTAT IN POLYCYTHEMIA VERA

Management of business projects, namely management of clinical trial projects in the nature of providing information management services; recruitment and selection of personnel and experts for clinical trials; business management of clinical trials; outsourcing services in the nature of arranging service contracts for others in the field of pharmaceutical development and clinical research; records management services, namely indexing of documents for third parties, especially coordination and control of electronic and paper document flow; database management services in the field of pharmaceutical product development, namely, preparation of case report forms (CRFs); collection and compilation of data into a central storage in the field of clinical trials; compilation and provision of statistical and biostatistical information in the nature of statistical analysis and reporting services for business purposes; medical coding services for third parties, namely coding of clinical trial data for the purposes of medical science and of regulatory reviews and approvals in the nature of compilation and systemization of information into computer databases; compilation of data into computer databases for the purpose of medical science research and medical consultation; regulatory document submission management, namely compiling dossiers in electronic common technical document formats, annual reports, management of article submissions in the nature of records management services, namely document indexing for others.

Education services, namely conducting seminars, conferences, workshops, and training sessions in the field of clinical trial management, pharmaceutical development, and regulatory compliance; training services in the field of clinical trial coordination, biostatistics, and data management; organization and execution of conventions, events, congresses, seminars, conferences, symposia, and exhibitions in the field of pharmaceutical and medical research; publication of texts, other than publicity texts; on-line publication of books and specialized magazines; multimedia publication of magazines, specialized magazines and newspapers; arranging and organization of meetings in the nature of seminars, workshops and social entertainment events, namely networking events in the field of pharmaceutical drug development and clinical research; regulatory document submission management, namely publishing presentations as printed matter.

Scientific and technological services namely scientific research, analysis, testing, and data computer modeling services in the field of pharmaceutical development, clinical trials, and medical technology; scientific services and scientific research, namely conducting scientific pharmaceutical product feasibility studies and product designing medical devices and instruments for clinical trials; scientific services and product design, namely conducting scientific pharmaceutical product feasibility studies and designing medical devices and instruments for clinical trials; platform as a service (PAAS) comprising software platforms for the transmission of images, audiovisual content, video content and messages; scientific research for medical purposes; product research services, design and development of instruments for control and diagnostics; computer diagnostic services, computer system analysis services; scientific research; electronic data storage; technical writing, namely medical writing services for clinical protocols, study reports, and regulatory dossiers; providing online non-downloadable software featuring clinical study and clinical trial management system tools via a website; electronic storage of files and documents; providing online non-downloadable software providing access to study management files; programming of software for study management files and electronic storage services for archiving temporary files throughout the clinical study lifecycle; scientific research, namely programming of software for biostatistics, development of protocols for sample size and statistical power calculations, randomization plans, and statistical analysis plans; providing online non-downloadable software enabling interpretation and reporting of data for clinical trial reports and publications; product development for others; scientific research, namely intermediate analysis for early decision-making in clinical trials; providing online non-downloadable software for providing access to databases and data lists ready for a New Drug Application (NDA), regulatory submission-compliant data files, study data tabulation, and data on model regulatory submission standards; medical research and development for new products for others in the field of medical surveillance and safety plans; pharmaceutical drug development services; drug discovery services of adverse events from clinical trials; pharmaceutical drug development services, namely development of safety update reports, management safety plans, and medical surveillance plans; product quality testing of clinical trial's documentation, for example, standard operating procedures (SOPs) and work instructions, internal system reviews, site audits, provider evaluations; medical research in the field of pharmacology, namely study design optimization, and modeling of pharmacokinetic population and pharmacodynamic interactions; Information related to scientific and medical research in the area of clinical trials, namely the design of clinical trials and outcome measures for studying human diseases, or studying or testing drugs, devices, or medical treatment methods on humans; Custom computer programming in the field of image training and integration into computer systems of suitability data with interactive response technology (IRT); Product design and development of computer databases for the collection, storage, management, analysis, and validation of data for use in the medical and pharmaceutical fields; Electronic data storage services for archiving presentations.

Regulatory compliance consultancy, namely legal assistance to third parties in drafting and compiling applications for new drugs; legal services relating to the submission and lifecycle management of clinical trial applications to competent authorities, ethics committees, and regulatory agencies; legal assistance concerning the submission of amendments to applications for regulatory approval.